Managing a project

Once Ethics and R&D approvals have been granted the research team must:

Follow the protocol approved by the Research Ethics Committee (REC) and the R&D Office. Any amendment to the protocol must be approved by the REC and the R&D Office (for more on amending a study, go to http://www.hra.nhs.uk/?s=amendments)

Obtain informed consent from research subjects

Ensure that confidentiality is maintained

Ensure that human tissue and samples are used appropriately

Report any adverse events Make an annual report on progress of the project to the REC and R&D Office

Apply to the relevant REC for site-specific assessment for any subsequently enrolled research site

Maintain appropriate records

Co-operate with any audit or monitoring undertaken by the Trust or external agencies

Notify the REC and R&D Office when the project finishes

All amendments, both substantial and minor, made during the life of the study must be notified promptly to the R&D Department. You should submit to R&D all the documentation that is sent to the Ethics Committee at the same time to ensure there is no delay with R&D approval/acknowledgement.

Guidance on amendments and the relevant forms for submission can be found on the HRA website.

SAE Reporting and Pharmacoviligance

Researchers conducting CTIMPs including device trials should contact the Research Governance Team for advice on how SAE Reporting is processed and managed through the Trust. The R&D Office SOP on SAE Reporting and Pharmacoviligance plus template SAE report forms, process flow chart and guidance can be found in the Document Library.

Annual progress reports (APRs)

A progress report should be submitted to the Ethics Committee 12 months after the date on which the favourable opinion was given. A copy must also be submitted to R&D and MHRA (if relevant) at the same time. Failure to submit the report to the ethics committee can potentially nullify the favourable opinion received.

Annual safety reports

From 1st September 2011 the Annual Safety Reports have now changed to Development Safety Update Reports to fall in line with Eurpoean and International Reporting Requirments. For further information please refer to the link below:

End of study notification

R&D and Ethics Committee should be informed in a timely manner when your study has finished. If your study completed as per the End of Study definition in your protocol, you should submit the end of study notification form to Ethics, R&D and MHRA within 90 days (calendar days) of the study end date.

If your study terminates early for any reason, you must submit the end of study notification form to Ethics, R&D and MHRA within 15 days of the study end date.

The end of study notification form can be found at on the HRA website.

CTIMPS - For end of study and amendments, CTIMPs have their own form. Please ensure you complete the correct form when submitting to the relevant bodies.

Where applicable, amendments must also be sent to the MHRA for CTIMPs. Additional guidance can be found on the MHRA.